Drugs@FDA: FDA-Approved Drugs
Company: CURIUM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ULTRA-TECHNEKOW FM | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 0.25-3 CI/GENERATOR | SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| ULTRA-TECHNEKOW FM | TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR | 1-19 CI/GENERATOR | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/23/1973 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/30/2017 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/2015 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017243Orig1s046ltr.pdf | |
| 02/16/2015 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/2013 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017243Orig1s044ltr.pdf | |
| 02/18/2014 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017243Orig1s043ltr.pdf | |
| 11/18/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/2013 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/2013 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/21/2013 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/27/2006 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017243s028ltr.pdf |
| 10/15/2004 | SUPPL-25 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17243s025ltr.pdf | |
| 01/16/2003 | SUPPL-22 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17243scs022ltr.pdf |
| 04/19/2002 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1999 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/14/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/18/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/21/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1979 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/23/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1977 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1976 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/04/2015 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf | |
| 02/18/2014 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf | |
| 12/20/2013 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf | |
| 10/15/2004 | SUPPL-25 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf |